UCB is looking to expand the label on Cimzia on the back of impressive late-stage data for the monoclonal antibody in psoriatic arthritis.
The Belgian drugmaker has published top-line results from a Phase III study evaluating Cimzia (certolizumab pegol) in patients with adult onset active psoriatic arthritis (PsA). It shows that the drug, the only pegylated anti-tumor necrosis factor therapy on the market, demonstrated a clinically relevant and statistically significant improvement at week 12 in the signs and symptoms of PsA.
In the 48-week, 409-patient study were randomised to receive Cimzia (200 mg every two weeks or 400 mg every four weeks) or placebo. Initial analyses suggest that no new safety signals were observed and adverse events were consistent with those seen in other trials of the drug.
UCB chief medical officer Iris Loew-Friedrich said "we are pleased that Cimzia has the potential to also benefit patients living with PsA and we are currently preparing for submissions to the regulatory authorities later this year". The full set of results will be presented at upcoming major rheumatology congresses.
In the European Union, Cimzia, in combination with methotrexate is approved for the treatment of moderate to severe active rheumatoid arthritis in adults inadequately responsive to disease-modifying antirheumatic drugs including methotrexate. In the USA, it is also marketed for Crohn's disease, as well as RA.